MENARINI Group

Piero Rijli

Market Access Orchestrator

Piero Rijli has over 30 years of experience at the Menarini Group, where he currently serves as Corporate Director, Regulatory Activities and Market Access. He has held global responsibility for international regulatory affairs, pricing, and reimbursement, and serves on the Board of Directors of Menarini Ricerche. By 2015, responsibilities were consolidated with global market access, leading to his current position as corporate director, regulatory activities and market access for the Menarini Group.

Throughout these years, I have gained a wealth of experience, contributing to several acquisitions that drove the international expansion of the Menarini Group. My teams and I have secured approvals and launched new innovative medicines in over 100 countries across diverse therapeutic areas, from cardiometabolic and antiinfectives to our growing oncology presence in the US and Europe. This evolution of my role reflects a deeper integration of regulatory and commercial strategies, which is critical in today's complex pharmaceutical landscape.

In defining regulatory, pricing and market access strategies and policies, I ensure every approach aligns with the needs of our customers and patients. These functions are inherently focused on understanding and demonstrating the value of our medicines to healthcare systems, payers and ultimately, patients. Generating health economic and value evidence is a key part of our pricing and market access strategy. We aim to secure approvals and launch globally, adapting to the diverse requirements of over 100 countries worldwide.

Fostering a culture of collaboration and innovation is crucial. I have a successful track record in building "winning teams" in global regulatory affairs and global access functions. I am a curious, forward-thinking and pragmatic leader and mentor. My focus includes designing and implementing innovative solutions and delivering outstanding vision, strategy and results. To address both local regulatory nuances and overarching customer needs, we must integrate country requirements into our strategic planning, ensuring data is generated to support anticipated requirements. This requires aligning clinical development plans with stakeholders’ needs, even before pivotal clinical trials, and updating global deliverables. This holistic approach ensures that global strategies are adaptable to local market dynamics while remaining cohesive.

The broader biopharma regulatory function is increasingly exploring generative AI (GenAI) to automate content creation, analyze complex data and streamline core regulatory activities. Such technologies can enhance speed and quality of submissions, facilitating more efficient decision-making. For market access, new technologies are emerging, offering solutions for pharma companies to gather and analyze real-world evidence for value-based drug pricing agreements. These platforms collect real-world data and use intelligent algorithms to provide insights into clinical effectiveness and related costs. These advancements hold significant potential for accelerating access to innovative therapies by making processes more efficient, data-driven and transparent.

Balancing Compliance and Value for Stakeholders

In regulatory affairs, my experience includes extensive interaction with health authorities and public institutions globally, managing databases for registrations of thousands of marketing authorizations and developing corporate policy procedures, SOPs and WIs to ensure full compliance. Simultaneously, in market access, my experience covers managing pricing and reimbursement for new corporate products. This involves interacting with key stakeholders and focusing on value generation and HEOR models.

Our strategies must adapt to a fragmented market where patients can wait significantly longer for access in some countries than in others. We must ensure our value propositions resonate despite disparities in healthcare infrastructure, economic viability or pricing and reimbursement processes that can be outside of a company's control.

As a leader and mentor, I aim to inspire my teams to embrace innovative thinking and take calculated risks by fostering an environment that values curiosity, forward thinking and pragmatic problem-solving. My leadership involves providing strategic input and support, with a focus on designing and implementing innovative solutions and delivering outstanding vision, strategy and results. We navigate complex and often uncertain landscapes, which necessitate a proactive and adaptive mindset from the teams. The constant developments of the access environment worldwide are pushing the industry towards greater cross-functional collaboration and strategic planning. I encourage teams to think beyond traditional silos and contribute to a unified strategy. I promote a culture where new ideas are welcomed and evaluated for their practical impact.

Market Access Through Strategic Leadership

My one piece of advice for all the emerging leaders in this sector would be to cultivate a holistic and deeply integrated understanding of both regulatory science and market access dynamics, always keeping patient access at the forefront.

You must strengthen cross-functional collaboration and embed regulatory and market access requirements into your strategic planning from the outset of clinical trials to anticipate evidence generation gaps and minimize delays. Developing a clear roadmap that aligns internal processes with external stakeholders’ engagement is essential.

Navigating these hurdles is critical, not only by ensuring compliance but also effectively demonstrating the value of innovative therapies to diverse stakeholders—payers, healthcare providers and patients. Ultimately, true leadership in this space means being a curious, forward-thinking, pragmatic leader and mentor who can build winning teams capable of designing and implementing innovative solutions that deliver both outstanding business results and, most importantly, timely and equitable access to medicines for patients worldwide.